Extensive revisions to the Toxic Substances Control Act (TSCA) were signed into law almost two years ago and the U.S. Environmental Protection Agency (EPA) has been extraordinarily busy implementing the many Congressional mandates set out under the law that amended it, the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The new law was one of the last acts of Congressional bipartisanship and, given the rancor that is now rooted in our hyper-partisan Congress, agreement on environmental legislation this sweeping is not expected again anytime soon.

Unsurprisingly, the three core rules outlining critically important aspects of the revised law, referred to as the TSCA “framework rules,” have all been judicially challenged. In August 2017, Safer Chemicals, Healthy Families and 11 other organizations sued EPA in the U.S. Court of Appeals for the Ninth Circuit challenging the Risk Prioritization and the Risk Evaluation final rules.Other organizations similarly filed suit over the same rules in the Second Circuit (Environmental Defense Fund (EDF) in New York) and in the Fourth Circuit (Alliance of Nurses for Healthy Environments in Virginia).The challenges to the Risk Prioritization rule were consolidated in the Ninth Circuit on November 27, 2017 (Safer Chemicals, Healthy Families v. EPA, Nos. 17-72260, et al.) and the challenges to the Risk Evaluation rule were consolidated in the Ninth Circuit on December 11, 2017 (Alliance of Nurses for Healthy Environments v. EPA, Nos. 17-73290, et al.).Industry trade association and other chemical interests motioned to intervene in these challenges, which the Ninth Circuit granted. The remaining framework rule, the Inventory Notification rule, was judicially challenged by EDF last September in the U.S. Court of Appeals for the D.C. Circuit (EDF v. EPA, No. 17-1201).Industry trade groups and others have been granted leave to intervene in the case.

Of particular note is another challenge filed on January 5, 2018, by the Natural Resources Defense Council (NRDC) in the U.S. Court of Appeals for the Second Circuit (Second Circuit) of what it characterized as an EPA “final rule” that was released on November 7, 2017, titled “New Chemicals Decision-Making Framework:Working Approach to Making Determinations under Section 5 of TSCA.”The draft Framework Document, as it has come to be called, is the final rule at issue and was posted in EPA’s docket opened for comments related to its two TSCA public meetings that took place last December. It is reasonable to assume that the Framework Document is decidedly not referred to by EPA as a final rule and was not published in the Federal Register as a final rule because EPA believes it is a document that outlines a “conceptual approach” to how EPA may go about making decisions on new chemicals. The document appears in the “supporting & related material” section of the meeting notice. EPA specifically states that the document, referred to as a “draft” in the Federal Register notice that announced the two public meetings, “outlines EPA’s approach to making decisions on new chemical notices submitted to EPA under TSCA section 5, as amended,” and includes EPA’s “general decision framework for new chemicals” and a breakdown of how EPA “intends to approach each of the five types of new-chemical determinations required under the statute.”

NRDC’s opening brief was submitted on May 1, 2018. It is an excellent read on the topic of why NRDC believes the draft Framework Document is actually a final rule in disguise that EPA implemented without the requisite process required under the Administrative Procedure Act.

The law suit raises novel and interesting procedural issues. Is the draft Framework Document a final, reviewable rule amenable to judicial appeal as final agency action? If the Court chooses to address the substantive TSCA issues, a key one relates to how EPA interprets “not likely to present an unreasonable risk” in reviewing TSCA Section 5 new chemical notifications, and what exactly Congress meant by “the circumstances … under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.” Is EPA misapplying the new language in Section 5 that NRDC claims is mandatory, or is EPA properly exercising its authority under Section 5 in identifying conditions of use as outlined in the Framework Document in conducting its Section 5 reviews?

These are hard questions and much depends on their outcome. For TSCA new chemical aficionados, understanding “conditions of use” is the Holy Grail, and any judicial gloss a reviewing court offers is expected to have a profound impact on how EPA reviews new chemicals and, thus, how and when new chemicals will be commercialized in the U.S.

American College of Environmental Lawyers, The ACOEL, is a professionalassociation of lawyers distinguished by experience and high standards in the practice of environmental law, ethics, and the development of environmental law.